Kornimate/medical-research-clean huggingface dataset:
tissue engineered nasal cartilage for reconstruction of the alar lobule

Conditions: Skin Carcinoma

Summary: the purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes within a collagen type i/iii membrane, in the alar lobule of patients after resection of a non melanoma skin cancer.

skin cancer is the most prevalent reason for surgically creating a multilayer defect, consisting of skin and cartilage, of the alar lobule of the nose. in reconstruction of these defects, a combination of local flaps and autologous cartilage, typically harvested from the nasal septum or the ear, is used to restore the stability, function and proper 3d shape of the alar lobule. harvesting autologous cartilage from the ear has been associated with a number of complications that could be overcome by the use of engineered cartilage graft generated in vitro with autologous cells. this study is a phase i, prospective, uncontrolled, investigator initiated clinical trial involving 5 patients, with the objective of demonstrating safety and feasibility in the use of engineered nasal cartilage grafts. the specific surgical target of the trial is the reconstruction of a two layer defect of the alar lobule using a tissue engineered nasal cartilage graft and a local flap, following resection of a non melanoma skin cancer.

Eligibility criteria:
inclusion criteria: * size of defect: ≥50% of alar subunit * extent of defect: 2 layer defect: skin and fibro-cartilaginous tissues exclusion criteria: * defect extent:3 layers defect, including mucosa * defect extent: 1 layer defect * pregnancy * immunodeficiency hiv * hepatitis b, c * allergy to porcine collagen, penicillin or streptomycin * chronic treatment with steroids or growth factors (immunomodulatory drugs)

Keywords: nasal cartilage diseases
study of enbrel in rheumatoid arthritis (ra) subjects with comorbid disorders

Conditions: Rheumatoid Arthritis

Summary: the objective of this study was to evaluate the safety of enbrel (etanercept) in rheumatoid arthritis (ra) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.


Eligibility criteria:
inclusion criteria: - active ra - documented comorbid condition (diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; history of pneumonia in the last year; or recurrent bronchitis, sinusitis or urinary tract infection) - able to self-inject study drug exclusion criteria: - previous use of anti-tumor necrosis factor (tnf) monoclonal antibody - receipt of anti-cd4 or diphtheria interleukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute t cell count - receipt of intra-articular corticosteroids within 2 weeks before screening - receipt of cyclosporine, thalidomide or azathioprine within 4 weeks before screening - significant concurrent medical diseases (serious infection; open cutaneous ulcers; current antibiotic treatment; myocardial infarction \[mi\] within 12 months of screening; angina pectoris; uncontrolled hypertension; cancer; or hiv positive)

Keywords: rheumatoid arthritis and at least 1 qualifying comorbid condition (diabetes, chronic pulmonary disease, recent infection) ra rheumatoid arthritis
register and dna bank of adult extra-hospital sudden death (protocol faster)

Conditions: Extra-hospital Sudden Death

Summary: the main objective of this study is the formation of a dna bank to realise a case-control genetic study designed to identify sequence variations in dna that predispose to sudden cardiac death in adults. the secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.


Eligibility criteria:
inclusion criteria : * inclusion criteria for register : * adults ≥ 18 years of age. * persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes. * patients not hospitalized at the time of sudden death. * inclusion criteria for dna bank : * case subjects : * adults ≥ 18 years of age. * persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes. * patients not hospitalized at the time of sudden death. * patients supported clinically by an emergency ambulance service. * control subjects : * adults ≥ 18 years of age. * adults hospitalized in an cardiac intensive care unit. exclusion criteria : * exclusion criteria for register : * violent death : criminal, suicidal or accidental. * exclusion criteria for dna bank : * case subjects : * violent death : criminal, suicidal or accidental. * identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause. * in accordance with articles l1221-5 l1221-l1221-8 and 8-1 of the code of public health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people : * adult subject to legal protection measure, * pregnant woman, * parturient, * breastfeeding mother, * person deprived of liberty, * person hospitalised without his consent, * person admitted to a medical or socially facility. * control subjects : * history of sudden death, * documented history of ventricular fibrillation, * history of sustained ventricular tachycardia (lasting longer than 30 seconds) documented.
evaluatation of appscent device safety and effectiveness for relief of obstructive sleep apnea (osa) syndrome in adults.

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. the standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (cpap). the major disadvantage of cpap is the relatively low compliance. appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . mildly trigeminal and pure olfactory odorants do not arouse or wake.

obstructive sleep apnea (osa) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. osa lead to desaturation and often lead to an arousal. associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems. the standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (cpap). cpap acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. the major disadvantage of cpap is the relatively low compliance. appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . mildly trigeminal and pure olfactory odorants do not arouse or wake. odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .

Eligibility criteria:
inclusion criteria: 1. osa diagnosed; ahi≥20 2. male and female aged 40 to 70 years old 3. patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. effective methods of contraception must be used throughout the study 4. bmi\< 35 5. patient is willing and able to give his/her written informed consent exclusion criteria: 1. chronic lung disease (including asthma and copd) 2. congestive heart failure 3. exhibiting any flu-like or upper respiratory illness symptoms at time of assessment 4. history of severe nasal allergies or sinusitis or difficulty breathing through the nose 5. persistent blockage of one or both nostrils 6. any previous operation or trauma to the nose 7. previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure 8. any use of antipsychotic, hypnotic drugs 9. major neurological diagnosis 10. active malignant disease including chemotherapy or radiotherapy treatment 11. pregnant or lactating women 12. drug abuse 13. medical history of epilepsy
impact of the piksec app on intravenous insertion success, pain, and emotional manifestation in pediatric patients: a non-randomized controlled trial

Conditions: Nurse's Role; Peripheral Venous Catheterization; Pain; Emotional Stress

Summary: the study employed a post-test non-randomized controlled trial to assess the impact of the pi̇kseç (peripheral intravenous catheter selection) application on the success of peripheral intravenous catheter (pivc) placement, as well as on the pain and emotional level scores of hospitalized preschool children aged 3-6 years. in preschool children, aged 3-6 years, who were hospitalized, anxiety about losing body integrity is commonly observed. children tend to think that all the material inside their bodies can come out through a wound or hole during invasive procedures. therefore, it becomes crucial to reduce anxiety related to invasive procedures in children of this age group. in this context, the study aimed to be conducted in preschool children.


Eligibility criteria:
inclusion criteria: * being a child in the 3-6 age group * pivc to be inserted * parents volunteering their child to participate in the study and signing the consent form * parents are literate exclusion criteria: * physical and mental disabilities, * the parent has an obstacle to communication (being mentally stable, etc.)
efficacy and safety of bromfenac ophthalmic solution in cataract surgery

Conditions: Cataract

Summary: efficacy and safety of bromfenac ophthalmic solution in cataract surgery


Eligibility criteria:
inclusion criteria: * scheduled for cataract surgery exclusion criteria: * known hypersensitivity to bromfenac and salicylates

Keywords: cataract extraction intraocular lens implantation
apixaban vs enoxaparin following microsurgical breast reconstruction-an rct

Conditions: Venous Thromboembolism

Summary: subcutaneous enoxaparin is currently the gold standard for vte chemoprophylaxis. however, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in vte events despite guideline-compliant prophylaxis. a population at particular risk is the growing number of patients who undergo autologous breast reconstruction. direct oral anticoagulants (doac) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic surgery.


Eligibility criteria:
inclusion criteria: * adult (\>18 years) women * scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous \[tram\] and/or deep inferior epigastric artery perforator \[diep\]) flap) * caprini score of 6 or greater. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * contraindication to the use of apixaban or enoxaparin * active bleeding * history of bleeding disorder * history of coagulopathy * history of heparin-induced thrombocytopenia * history of liver disease * history of renal disease (creatinine clearance \ 1.6 mg/dl) * major neurosurgical intervention (brain/spine) within the past 90 days * ophthalmologic procedure within the past 90 days * uncontrolled hypertension * history of alcohol and/or substance abuse * need for therapeutic anticoagulation * pregnant or nursing
lomecel-b delivered during stage ii surgery for hypoplastic left heart syndrome (elpis)

Conditions: HLHS

Summary: this study is designed to assess the safety, tolerability, and efficacy of lomecel-b as an adjunct therapy to the standard stage ii (bdcpa) surgical intervention for hlhs. lomecel-b will be delivered via intramyocardial injections

this study is designed to assess the safety, tolerability, and efficacy of lomecel-b (formerly lmscs) as an adjunct therapy to the standard stage ii (bdcpa) surgical intervention for hlhs, which is typically performed at 4 - 6 months after birth. lomecel-b will be delivered via intramyocardial injections. a total of 30 patients will be enrolled in 2 stages with 3 cohorts. in the first stage, 10 consecutive hlhs patients will be enrolled and treated with lomecel-b (cohort a). the first 3 patients will be treated no less than 5 days apart, and will be evaluated for any treatment-emergent adverse events (te-aes) (e.g., induced myocardial infarction or perforation). these patients will undergo full evaluation for 5 days to demonstrate safety prior to proceeding with the remainder of the cohort. after 6 months post-treatment of the last patient of cohort a, a formal safety review will be conducted prior to proceeding to the next phase. the second stage is double-blinded, in which 20 hlhs patients will be randomized to either receive treatment with lomecel-b (cohort b, 10 patients), or will receive no cells and no injection (cohort c, 10 patients).

Eligibility criteria:
inclusion criteria: all patients must have hlhs (all types) requiring bdcpa surgery. exclusion criteria: all patients must not have any of the following. 1. significant coronary artery sinusoids. 2. requirement for mechanical circulatory support prior to bdcpa surgery. 3. underlying evidence of arrhythmia requiring anti-arrhythmia therapy. 4. need for concomitant surgery for aortic coarctation or tricuspid valve repair. 5. hlhs and restrictive or intact atrial septum. 6. undergoing the stage i (norwood) procedure that does not have hlhs. 7. serum positivity for: hiv; hepatitis b virus surface antigen (hbv bsag); and/or viremic hepatitis c virus (hcv). 8. parent/guardian that is unwilling or unable to comply with necessary follow-up. 9. unsuitability for the study based on the investigator's clinical opinion. 10. documented chromosomal abnormalities

Keywords: pediatrics
breath metabolomics of placebo effects, a pilot study

Conditions: Analgesia

Summary: this study is to analyze the breath metabolome before and after the administration of a placebo in an established experimental pain procedure in healthy subjects in order to investigate placebo effects, and whether they induce any measurable changes at the metabolic level.

interrogation of the exhaled breath metabolome will be performed by using an objective method of measurement for placebo effects in pain analgesia, known as cold pressure test (cpt). cpt reactions can be measured objectively by blood pressure spikes as well as changes in continuous heart rate monitoring.to this end, probands will be continuously connected to a heartrate \& blood pressure monitor. first, baseline exhalation will be assessed. then, the cpt is performed according to the 'cpt guide' with subsequent post-pain exhalations analysis with or without self-administration of the placebo (nacl nasal spray). after 15 minutes rest, probands will be submitted to a second post-pain exhalations set (+/- placebo). the process is completely non-invasive as the participant just exhales through a commercially available disposable bacterial/viral filter coupled to the ion source.

Eligibility criteria:
inclusion criteria: * healthy female and male adult volunteers * german speaking, or good knowledge of the german language * able to understand the study * able to give informed consent exclusion criteria: * regularly taking medication potentially interfering with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers) * current pregnancy * daily smokers (as per who definition: a daily smoker is someone who smokes any tobacco product at least once a day.) * neuropathy * chronic pain * neuromuscular or psychiatric disease * known or suspected heart, kidney or liver disease * hypertension (systolic (mmhg) \>130, diastolic (mmhg) \>80) * history of fainting or seizures * history of frostbite * current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment.

Keywords: pain placebo effects analgesia placebo analgesia cold pressor test breath metabolomics
micra transcatheter pacing system post-approval registry

Conditions: Bradycardia

Summary: medtronic is sponsoring the micra registry to further confirm safety and effectiveness of the micra transcatheter pacing system (micra system) when used as intended, in "real-world" clinical practice, following commercial release. the micra registry is conducted within medtronic's product surveillance registry.

the micra registry is a global, prospective, observational, multi-site registry. patients enrolled in the micra registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the micra registry\*. enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all micra system follow-up patient visits are to be reported. therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. the total estimated registry duration is 11 years. \*patients contributing to an acute performance sub-study of the micra registry do not contribute to the fda-regulated post-approval study which includes a long-term (minimum 9-year) patient follow-up period.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient is intended to receive or be treated with a micra transcatheter pacing system and must be enrolled prior to the tps implant procedure exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
perifosine plus capecitabine versus placebo plus capecitabine in patients with refractory advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: the trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.


Eligibility criteria:
inclusion criteria: * patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for k-ras wild-type (wt) patients, anti-egfr antibody (cetuximab or panitumumab) containing therapies. * for oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity. * no prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine * patients must have at least one measurable lesion by recist criteria exclusion criteria: * patients with known dipyrimidine dehydrogenase (dpd) deficiency or prior severe reaction to 5-fu
origin and function of eosinophilic polynuclear during dress syndrome

Conditions: Drug Hypersensitivity; DRESS Syndrome

Summary: drug hypersensitivity syndrome or dress for "drug reaction with eosinophilia and systemic symptoms" is a serious drug allergy which can be life-threatening for patients with serious organ damage. the pathophysiology of dress is still not fully understood. in particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteria. likewise, there is no data about the origin of eosinophils and few data are available concerning immune polarization of t-cells or the involvement of innate lymphoid cells type 2 in the recruitment of eosinophils. our preliminary data on increase activation markers membrane expression of cutaneous eosinophils suggest that this approach could allow the identification of endotypes in which eosinophils are involved and contribute to organ damages. the correlation between tissue infiltration of eosinophils and their degree of activation would then justify the development of targeted therapeutic strategies in dress syndrome (anti-il-5 therapy?). the aim of the project is: 1) evaluate the activation status of circulating and cutaneous eosinophils in patients with dress compared with drug induced maculopapular exanthema without or with eosinophilia (but do not fulfill dress criteria) and healthy subjects; 2) understand the pathophysiological mechanisms at the origin of this eosinophilia.


Eligibility criteria:
inclusion criteria: group 1 (dress): adult with a diagnosis of dress based on the following four criteria: * cutaneous rash occurring at least 24 hours and at most 2 months after continuous medication use * fever over 38 degre celcius * at least one organ dysfunction among: * lymphadenopathy * hepatitis * pulmonary involvement * cardiac involvement: myocarditis, pericarditis * renal impairment * at least one of the following hematological anomalies: * eosinophilia ≥ 500 / mm3 . * regiscar score ≥ 4 groups 2 and 3 (drug induced maculopapular exanthema without or with eosinophilia). * adult with drug-induced rash * without clinical criteria of severity defined by djien among : * an evolution of more than 21 days * with organ damage as defined in group 1 group 2 (mpe without eosinophilia): blood eosinophils \< 500 / mm3 group 3 (mpe with eosinophilia): blood eosinophils ≥ 500 / mm3 exclusion criteria: * other cause of eosinophilia including cancer, blood disease before the introduction of suspected molecule(s). * on going oral or local corticosteroid therapy, anti-leukotriene therapy (montelukast) by the month preceding the study; * anti-ige therapy (omalizumab, ligelizumab), anti-il-5 therapy (mepolizumab, benralizumab) or anti-il4 and / or anti-il13 therapy (dupilumab, tralokinumab) in the 6 months preceding the study. * any pregnant or lactating woman. * contraindication related to the blood volume taken for the study.

Keywords: dress syndrome drug hypersensitivity eosinophils allergy